Title : Phase II Results: TMZ with DISULFIRAM and COPPER (SNO 2018)
link : Phase II Results: TMZ with DISULFIRAM and COPPER (SNO 2018)
Phase II Results: TMZ with DISULFIRAM and COPPER (SNO 2018)
Very many patients and their relatives (including me) were interested in the effect of a combination of disulfiram + copper. The disappointing results of this study are published in the SNO 2018 brochure:
"ACTR-19. A MULTICENTER PILOT PHASE II STUDY OF CONTINUING TMZ WITH THE ADDITION OF DISULFIRAM AND COPPER FOR REFRACTORY GLIOBLASTOMA"
BACKGROUND: Preclinical studies have suggested promising activity for the combination of disulfiram and copper (DSF/Cu) against glioblastoma (GBM) including re-sensitization to temozolomide (TMZ). A previous phase I study demonstrated the safety of combining DSF/Cu with adjuvant TMZ for newly diagnosed GBM. This pilot phase II study aimed to estimate the potential effectiveness of DSF/Cu to re-sensitize recurrent GBM to TMZ. METHOD: This open-label, single-arm phase II study treated recurrent TMZ-refractory GBM patients with TMZ 150mg/m2 on days 1–5 of every 28-day cycle with concurrent daily DSF 80mg TID and Cu 1.5mg TID. Eligible patients must have progressed after standard chemoradiotherapy and within 3 months of the last dose of TMZ. Known IDH-mutant or secondary GBMs were excluded. The primary endpoint was objective response rate (ORR), and the secondary endpoints included progression-free survival (PFS), overall (OS), clinical benefit (stable disease for at least 6 months), and safety. Evaluable patients must have received at least 28 days of DSF/Cu unless stopped due to progression, toxicity, or death.
RESULTS: From March 2017 to January 2018, 23 TMZ-refractory GBM patients were enrolled across seven centers in the United States, and 22 patients were evaluable. The median DSF/Cu duration was 48 days (range: 12–246 days). After a median follow-up of 4.4 months, there were no objective responses, with 6-month PFS of 14% and 6-month OS of 55%. Among 17 patients who had at least 28 days of DSF/Cu, 3 patients (18%) had clinical benefit.Grade 3 toxicities that were possibly related to DFS/Cu included fatigue, headache, anxiety, and elevated alanine transaminase (5% for each).
CONCLUSION: Addition of DSF/Cu to TMZ for TMZ-refractory GBM yielded minimal ORR but demonstrated clinical benefit for a subset of patients. DSF/Cu may have modest TMZ re-sensitization or single-agent activity for recurrent GBM.
Thus Article Phase II Results: TMZ with DISULFIRAM and COPPER (SNO 2018)
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